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Not yet recruiting NCT06804460

Effect of a Vegan Mediterranean Diet on Cardiometabolic Biomarkers, Functional Capacity, and Quality of Life in Patients with Fibromyalgia

Phase I Interventional Fibromyalgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dietary intervention.
Who it may be relevant to
Registry conditions: Fibromyalgia. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study aims to evaluate the effect of a vegan Mediterranean diet compared to a traditional Mediterranean diet on inflammatory biomarkers, functional capacity, and quality of life in patients with fibromyalgia.

Detailed description

The study involves two visits to the Exercise Physiology Research Laboratory at UFV. During the first visit, participants will complete functional capacity tests, respond to questionnaires (Fibromyalgia Impact Questionnaire, Short Form-36, MDF-Fibro-17, and Tampa Scale for Kinesiophobia), and provide a blood sample from the antecubital vein collected by an auxiliary nurse from the Eurofins MEGALABS laboratory. The biochemical markers to be analyzed include: white blood cell count (neutrophils, lymphocytes, monocytes, and platelets), lipid profile, fasting blood glucose levels and acute-phase proteins (C-reactive protein). Additionally, body composition will be assessed using a Tanita TBF300, and waist circumference will be measured. Functional capacity tests will include a handgrip strength test, a 30-second chair-to-stand test, and a timed up-and-go test. Participants will undergo a six-week dietary intervention and will return for a second visit at the end of the intervention period. They will be randomly assigned to follow either a vegan Mediterranean diet or a traditional Mediterranean diet, both of which will be guided and supervised by registered dietitians. These diets will be designed to meet individual energy needs and key nutrient requirements, following the standards set by the National Academy of Medicine and the Academy of Nutrition and Dietetics. Both diets will be isocaloric and maintain an identical macronutrient distribution. After the intervention, participants will repeat the same functional tests, questionnaires, and capillary blood measurements.

Interventions

  • Behavioral Dietary intervention
    The vegan mediterranean diet is mainly composed of whole plant-based foods, similar a una dieta mediterránea, but the animal sources of protein and fat are substituted with plant foods rich in protein and fat. During the vegan diet, participants are supplemented with 1000 µg of cyanocobalamin (vitamin B12) twice a week (Harrison Sports Nutrition, Granada, Spain) to compensate for the deficiency in vitamin B12 intake induced by the vegan diet.

Primary outcome measures

  • Neutrophil to lymphocyte ratio [Time frame: From enrollment to the end of treatment at 6 weeks]
  • Lipid profile [Time frame: From enrollment to the end of treatment at 6 weeks]
  • Cardiorespiratory fitness [Time frame: From enrollment to the end of treatment at 6 weeks]
  • Quality life [Time frame: From enrollment to the end of treatment at 6 weeks]
  • Metabolic health [Time frame: From enrollment to the end of treatment at 6 weeks]
Secondary outcome measures (5)
  • Metabolic health [Time frame: From enrollment to the end of treatment at 6 weeks]
  • Metabolic health [Time frame: From enrollment to the end of treatment at 6 weeks]
  • Strength performance [Time frame: From enrollment to the end of treatment at 6 weeks]
  • Quality Life [Time frame: From enrollment to the end of treatment at 6 weeks]
  • Quality life [Time frame: From enrollment to the end of treatment at 6 weeks]

Eligibility criteria

Inclusion criteria

  • Adults aged between 18 and 50 years.
  • Participants with a Fibromyalgia diagnosis according to the American College of Rheumatology (ACR) criteria.
  • Functional independence.
  • Non-smokers.
  • Low alcohol consumption (<1 serving/day).
  • Pharmacological treatment stabilized for at least 4 weeks prior to the start of the study.

Exclusion criteria

  • Pregnant, lactating, or menopausal women.
  • Physical condition that prevents the performance of functional capacity tests.
  • Change in pharmacological therapy during the intervention period.
  • Concomitant inflammatory conditions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06804460 · AGL-2024-46 project

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗